Monday, November 10, 2008
ScienceDaily (Nov. 6, 2008) — A new study published in Journal of Neuroimaging shows that MRI scans used on multiple sclerosis (MS) patients to determine if the disease has affected gray matter in the brain can identify those at-risk for progression of disability.
MS affects approximately 400,000 people in the United States and as many as 2.5 million worldwide. It is the most common cause of progressive disability in young adults. While the cause of the disease remains unknown, it is characterized by damage to the covering over the nerve fibers in the brain and spinal cord, or to the nerve fiber itself.
In an attempt to understand the causes of disease progression, researchers at the Partners MS Center, led by Dr. Rohit Bakshi and his team, have developed new ways to detect gray matter damage.
Dr. Bakshi, Director of the Laboratory for Neuroimaging Research and an Associate Professor of Neurology and Radiology at the Brigham and Women's Hospital and Harvard Medical School, led a four year follow-up study, which found that patients with unnatural darkness of gray matter structures as seen on MRI pictures carried a higher risk for progression of physical disability. This abnormal darkness is referred to as T2 hypointensity, and is suggestive of excessive iron deposits. In addition, the researchers found that the new marker of gray matter damage showed closer correlations with patients' clinical status than other established MRI markers of disease severity, including lesions, also known as "plaques," and shrinkage of the brain, also know as "atrophy."
"MRI scans obtained from patients with MS are being used to develop measures and techniques that can accurately measure the visible and hidden damage to the brain, especially in gray matter areas and can more accurately predict the course of the disease," says Bakshi.
As a result of the findings, MRI-based measurement of gray matter damage may be used as a surrogate marker of disease progression. Physicians may therefore be able to more accurately identify patients at risk for developing this progressive disease.
MS has been traditionally viewed as a disease affecting the white matter of the brain, where messages are transferred between the brains gray matter sections, which control the processing of information. While prior research has shown that the brain's gray matter is also affected, studies detailing its effects have been limited. In addition, current therapies for MS are incomplete, raising the need to better understand disease mechanisms and the biomarkers of disease progression. If excessive iron in gray matter contributes to damage, this would open a new avenue for developing better therapies.
1. Neema et al. Deep Gray Matter Involvement on Brain MRI Scans Is Associated with Clinical Progression in Multiple Sclerosis. Journal of Neuroimaging, 2008; DOI: 10.1111/j.1552-6569.2008.00296.x
Adapted from materials provided by Wiley-Blackwell, via EurekAlert!, a service of AAAS.
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ALAMEDA, Calif., Nov 3, 2008 (GlobeNewswire via COMTEX News Network) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company innovating therapeutics for neurological care, today announced a significant restructuring of the company aimed at preserving cash and reassessing its strategic opportunities. As a result of the restructuring, which will involve staff reductions of over 70 percent of the company's total workforce, Avigen expects to have sufficient cash to fund operations for over four years.
"Our deepest gratitude goes out to all the talented and dedicated employees who have worked so hard to complete a timely and well executed AV650 clinical program, as well as enhance the value of our other clinical-stage drug candidates from our internal research and development," said Kenneth Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer. "By reducing to only a core team, however, we can significantly lower our infrastructure costs, while retaining the know-how and expertise necessary to monetize our current assets and identify opportunities to acquire new assets. We believe our strong cash position and management team will make Avigen an attractive partner in this challenging financial climate."
-- Avigen expects to end 2008 with top-line cash and securities of
approximately $49 million and believes this restructuring
will extend its resources to support at least four years of
operations, including providing funds to develop one asset to a
meaningful value inflection point without additional equity
-- Avigen's contract with Sanochemia Pharmaceutica AG regarding
AV650 has been terminated to avoid further payment obligations
on the part of Avigen.
-- Avigen believes the breadth and value of AV411 can be best
realized with the support of a partner; therefore, Avigen
intends to seek a partner and does not currently plan to
initiate the Phase 2b development program for neuropathic
pain. Current and future National Institute on Drug Abuse-funded
Phase 2a trials in opioid withdrawal and methamphetamine relapse
-- Proceeds from the sale or partnering of Avigen's current assets
(AV411 and AV513) could significantly increase its cash position
and its ability to develop additional assets to meaningful value
inflection points without additional equity financings.
"Our experienced team has faced similar challenges, and has demonstrated the ability to take decisive action to create valuable opportunities," said Dr. Chahine. "Given the current economic environment, we believe this strategy represents a sound plan that will not only withstand, but capitalize on, the current market conditions."
AV411 is a first-in-class orally bioavailable small molecule, a glial attenuator that suppresses pro-inflammatory cytokines IL-1 beta, TNF alpha, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10. While considered a New Molecular Entity (NME) in the United States and Europe, the drug was first approved in Japan more than 15 years ago. The drug has been prescribed to over one million patients for a different indication and has a good post-marketing safety profile in nearly 15,000 patients studied at the prescribed doses.
Glial activation in the brain and spinal cord contribute to the establishment and amplification of the chronic pain state. As part of its program investigating glial attenuation as a novel approach to the treatment of neuropathic pain, Avigen discovered that AV411 (ibudilast) was efficacious in standard preclinical models of opioid withdrawal. While ibudilast was initially developed as a non-selective phosphodiesterase (PDE) inhibitor for the treatment of bronchial asthma, its efficacy in neuropathic pain models appears to be independent of this activity. AV411 has advanced through Phase 1 and 2a clinical trials for neuropathic pain and is currently in a NIDA-funded trial with Columbia University addiction research specialists for opioid withdrawal. Additional preclinical research has revealed that AV411 can attenuate opioid-induced glial activation and both behavioral and neurochemical markers of opioid-induced reward and withdrawal. Moreover, collaborative studies with NIDA have revealed utility in methamphetamine relapse in animals which is being translated to a NIDA-funded exploratory clinical trial with UCLA investigators in 2009. Based on its research, Avigen has filed for patents protecting the use of AV411, as well as for patents on AV411 analogs which the company believes have the potential to be effective second generation molecules. Additional information on AV411 can be found on Avigen's website at www.avigen.com.
Avigen is a biopharmaceutical company focused on developing and commercializing unique small molecule therapeutics to treat serious neurological disorders, including neuropathic pain and opioid addiction and withdrawal. Avigen's strategy is to complete the requirements of clinical development for each of the candidates in its product pipeline, and continue to look for opportunities to expand its pipeline through a combination of internal research, acquisitions and in-licensing, with the goal of becoming a fully integrated commercial biopharmaceutical company that remains committed to its neurology products. Avigen is currently developing AV411 for neuropathic pain, as well as opioid withdrawal and addiction in collaboration with NIDA. Additionally, the company is advancing AV513, a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B, toward clinical trials. For more information about Avigen, consult the company's website at www.avigen.com.
The Avigen, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=2981
Statement under the Private Securities Litigation Reform Act
This press release contains forward-looking statements, which include, among others, statements relating to Avigen's expectations that the current restructuring and staff reduction will reduce its infrastructure costs and extend its financial resources to support at least four years of operations without additional equity financings; that it will retain the know-how and expertise necessary to monetize its current assets; that it will be able to identify and acquire new assets; that it will be able to secure a partner to initiate the AV411 Phase 2b development program for neuropathic pain; that current and future National Institute on Drug Abuse-funded trials in opioid withdrawal or methamphetamine relapse will continue; that Avigen can avoid further payment obligations to Sanochemia beyond those already paid; that it will be able to take any asset to a meaningful value inflection point with or without additional equity financings; that it can generate any proceeds from the sale or partnering of current assets; and that the Company's current strategy will allow it to withstand or capitalize on the current market conditions. These risks and uncertainties include: unexpected expenses incurred with respect to the restructuring may occur; savings from the restructuring may not be as much as Avigen expects due to unexpected impediments to reducing expenses; in this economic environment, Avigen may not be able to find a partner for AV411 on terms favorable to Avigen; that costs necessary to bring products to a meaningful inflection point may be more than Avigen expects; and those detailed in reports filed by Avigen with the Securities and Exchange Commission, including Avigen's quarterly report on Form 10-Q for the period ended June 30, 2008, under the caption "Risks Related to Our Business" in Item 2 of Part I of that report, which was filed with the SEC on August 11, 2008.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Avigen, Inc.
Michael Coffee, Chief Business Officer
1301 Harbor Bay Parkway
Alameda, CA 94502
[November 3, 2008]
By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) - Source MDx has formed a partnership with Boston’s Brigham and Women’s Hospital to study RNA-based biomarkers for multiple sclerosis, the company announced today.
The duo plans to use expression profiling to find diagnostic markers, markers for active or stable MS, and response markers for currently available MS therapies.
Multiple sclerosis, a chronic central nervous system inflammatory disease, has unpredictable and highly variable progression. For instance, many individuals with the disease experience partial or complete remission punctuated by MS relapses whereas others experience progressively worse symptoms. Current methods for determining the stage of disease are imprecise, but some research suggests that gene expression profiles could help map disease progression and guide treatment, the companies said.
“Our objective is to evaluate RNA-based markers in the broader context of each patient’s genetics, protein markers, family history, and clinical information in order to determine markers that can help in making a diagnosis of MS and prognosticate on drug response in MS,” Brigham and Women’s Hospital neurology researcher Phil De Jager, co-leader of the study, said in a statement. “By doing so, we hope to be better able to identify makers that could lead to improved diagnostic tools, therapies, or treatment regimen.”
The research ties into ongoing work by De Jager and Brigham and Women’s molecular immunologist David Hafler and others in the International Multiple Sclerosis Genetics Consortium and Partners Healthcare MS Center.
Source MDx said that it has patented the use of gene expression data for identifying, monitoring, and treating MS. The company added that it has identified and patented MS gene expression biomarkers linked to MS in independent studies by De Jager and Hafler.
Medigait LLC announces the release of a new device that combines virtual reality programming and real-time motion detection into a cell-phone sized device that helps MS patients restore their ability to walk more normally. The neuroplastic brain response stimulated by this device helps MS patients jump-start the rewiring process inside the patient's brain. Their brain literally rewires itself creating new healthy walking circuits bypassing diseased areas sometimes in as little as two weeks.
When I saw these positive results I was amazed, very excited, and gratified.
Haifa, Israel (PRWEB) November 3, 2008 -- Studies performed over the last few years show many Multiple Sclerosis (MS) patients no longer have to live with a meandering or unsteady gait caused by their disease. According to a study published in the highly acclaimed medical journal "Neurology", closed-loop visual feedback helps MS patients improve their walking. Both stride length and walking speed improved dramatically helping MS patients walk safely.
Better yet, a study published in the "Journal of Neurological Sciences" found that when closed-loop auditory feedback was combined with visual cues, MS patients showed even more improvement and confidence while walking.
Based on concepts discovered while working on a NASA project helping helicopter pilots to safely navigate around tall objects, Professor Yoram Baram, CEO of Medigait LLC, created the GaitAid Virtual Walker. The Virtual Walker is a highly sophisticated device about the size of a cell phone paired with a set of high-tech eyeglasses. Professor Baram designed this device specifically to help patients with MS and other movement disorders regain their stability while walking.
Medigait announces the re-introduction of the GaitAid Virtual Walker to the market after locating a reliable high quality US-based medical device company to build the device for them.
The GaitAid Virtual Walker combines proven visual aids and audio feedback helping patients with MS and other movement disorders improve their stability while walking through a process called neuroplasticity. This process essentially rewires the patient's brain by creating new healthy circuits to bypass disease-damaged areas.
The National Multiple Sclerosis Society estimates there are approximately 400,000 people in the United States with MS. World-wide about 2.5 million people suffer from MS.
Because MS afflicts both the central and the peripheral nervous systems, not all MS patients show the same symptoms. However, a large percentage of MS patients exhibit loss of balance and muscle coordination affecting their ability to walk safely. Although a cure for MS hasn't been found, the GaitAid Virtual Walker offers a safe, effective, and non-pharmacological method of helping MS patients walk better leading to more productive and safer lives.
Clinical studies have shown major improvements to walking speed and stride length in 70% to 85% of MS and other movement disorder patients. Some patients have been helped to the point of no longer needing the device except occasionally to maintain their improvement.
Clinical studies appearing in medical journals, Neurology, Neural Processing Letters, and Journal of Neurological Sciences described the device as being effective but without the risk or possible adverse side effects caused by surgery and medication. Links to this information can be found at http://www.gaitaidmedical.net/studies.html
"When I saw these positive results I was amazed, very excited, and gratified." -- Professor Yoram Baram Phd.
"The results clearly indicate that the device helps patients with MS control their gait. The degree of improvement is proportional to the degree of impairment. The results support the potential role of the device as a rehabilitation modality in MS, and substantiate their specific implementation in efforts to alleviate, improve, and restore mobility in patients with gait disturbances due to neurological disorders in general." -- Ariel Miller, MD, Multiple Sclerosis Center, Carmel Medical Center and Rappaport Faculty of Medicine & Research Institute
For more information on the GaitAid Virtual Walker device:
Visit our website: http://www.medigait.com or
contact Amir Baram by calling 1-888-777-9906 (U.S) or email him at
support (at) medigait (dot) com
About MediGait LLC
MediGait was founded by Yoram Baram, who received his PhD degree from MIT and is presently a Professor of Computer Science and incumbent of the Roy Matas / Winnipeg Chair in Biomedical Engineering at the Technion, Israel Institute of Technology. The idea for this project was sparked 12 years ago while Professor Baram was designing a mechanism for NASA to navigate low-flying helicopters around obstacles. The concept of the design, which Baram later applied to the medical device, is that the optical images of objects help the observer navigate, stabilize and pace movement in space.
About the Technion Institute of Technology
The Technion-Israel Institute of Technology is Israel's leading science and technology university. Home to the winners of the Nobel Prize in science, it commands a worldwide reputation for its pioneering work in nanotechnology, electrical engineering, computer science, biotechnology, water-resource management, materials engineering, aerospace and medicine. The majority of the founders and managers of Israel's high-tech companies are alumni.